The generic drug maker Ranbaxy pleaded guilty on Monday to federal drug safety violations and will pay $500 million in fines to resolve claims that it sold subpar drugs and made false statements to the FDA about its manufacturing practices at two factories in India, the company and federal prosecutors announced Monday. The settlement is the largest in history involving a generic manufacturer and drug safety, the Justice Department said. Ranbaxy has been functioning under a consent decree with the Food and Drug Administration since last year after federal officials identified a host of manufacturing lapses at plants in India and one in the United States, and concluded that the company, which is a subsidiary of the Japanese pharmaceutical company Daiichi Sankyo, submitted false data to the F.D.A. Ranbaxy has not exported drugs from the two Indian factories, known as Paonta Sahib and Dewas, to the […]
Generic drug maker Ranbaxy pleaded guilty FDA safety violations and will pay fines to resolve claims that it sold subpar drugs and made false statements to the FDA. Call (302) 995-6210 for more info.
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